QA Engineering Manager — Medical Devices (Onsite Irvine)

glidewelldental; Irvine (CA); On-site; USD 114,000 - 152,000; Full time

Job summary

Glidewell Dental is seeking a senior Quality Assurance professional to lead a team in Irvine, CA. This onsite role drives product quality, regulatory compliance, and process improvements across new product development and contract manufacturing of medical products.

The role emphasizes management responsibilities, mentoring staff, and maintaining a robust QMS in alignment with ISO 13485 and SaMD considerations. Onsite work only in Irvine, with no remote option.

Qualifications

• Bachelor's degree in a related engineering discipline.
• Minimum seven (7) years of related quality assurance experience.
• Previous management and leadership experience.
• Advance knowledge with development and test requirements with recognized standards (ISO 13485).
• Previous experience with New Product Development.
• Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
• Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.

Responsibilities

• Ensures products meet customer requirements and complies with US and international regulations.
• Hires, manages, trains, develops, reviews, and sets goals for department and staff.
• Acts as coach and mentor to team members in problem solving, decision-making, and process improvement.
• Oversees the technical side of the Company’s quality system and processes for new product development and process improvement projects.
• Manages and ensures staff’s adherence to Company policies and procedures.
• Organizes procedures and documentation related to areas of responsibility.
• Participates in internal, external, and third party audits.

Skills

Quality Assurance

Leadership

ISO 13485

Software QMS

New Product Development

Audits

Education

Bachelor's degree in engineering

Tools

QMS

Job description

Glidewell Dental is seeking a senior Quality Assurance professional to lead a team in Irvine, CA. This onsite role drives product quality, regulatory compliance, and process improvements across new product development and contract manufacturing of medical products.

The role emphasizes management responsibilities, mentoring staff, and maintaining a robust QMS in alignment with ISO 13485 and SaMD considerations. Onsite work only in Irvine, with no remote option.